Contract Compliance and Quality Manager

Baxters North America; Cincinnati (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Baxters North America is seeking a Contract Compliance & Quality Manager to lead quality and regulatory efforts across military, government, and strategic accounts. You will interpret complex requirements, drive audits, corrective actions, and continuous improvement initiatives to ensure product and process compliance.

The role partners with Operations, Engineering, and Supply Chain to implement and maintain compliant practices, while guiding cross-functional teams and mentoring staff for growth

Qualifications

• Bachelor's degree in a related field or equivalent experience in a regulated industry.
• 5+ years in quality, compliance, regulatory affairs, or contract administration in a regulated setting.
• Experience auditing, managing corrective actions, and leading cross-functional teams.

Responsibilities

• Serve as the primary quality representative for military, government, and strategic accounts.
• Interpret customer specifications and regulations to ensure compliance across the organization.
• Develop, review, and administer waivers, deviations, and concessions with customers.
• Lead customer communications on quality concerns, investigations, and corrective actions.
• Establish and maintain quality management systems aligned with requirements.
• Lead audits and assessments by customers, government bodies, and third parties.
• Manage corrective actions from audits, complaints, and findings.
• Collaborate with Operations, Engineering, Supply Chain, and Programs departments to implement requirements.
• Conduct risk assessments and facilitate root-cause investigations to mitigate risks.
• Monitor changes to requirements and implement process improvements accordingly.
• Develop KPIs for compliance, quality, and customer satisfaction.
• Manage customer complaints, nonconformances, and verification activities.
• Build relationships with customer representatives and regulatory authorities.

Skills

Customer Requirements Management

Customer Relationship Management

Contract Compliance

Regulatory Compliance

Regulatory Reporting

Quality Assurance

Reliability Analysis

Audit Management

Risk Assessment

Root Cause Analysis

Leadership

Problem-Solving

Project Management

Decision-Making

Strong Communication Skills

Stakeholder Influence

Continuous Improvement

Operational Excellence

Education

Bachelor's degree in Quality Management / Engineering / Regulatory Affairs

Tools

Quality Management Systems (QMS)

Job description

Scope of Job

The Contract Compliance & Quality Manager is responsible for ensuring compliance with military, government, customer, contractual, and regulatory requirements. This role serves as the primary liaison between the organization and military/government customers, ensuring customer expectations, contractual obligations, and compliance requirements are effectively interpreted, communicated, and implemented throughout the organization.

The Contract Compliance & Quality Manager provides leadership for quality and compliance systems, customer audits, corrective actions, risk management activities, and continuous improvement initiatives. This position leads cross-functional teams to resolve customer issues, manage compliance concerns, and ensure all products, processes, and programs meet applicable customer, contractual, and regulatory requirements. The role also fosters strong relationships with customer representatives, government agencies, auditors, and other external stakeholders.

Essential Job Functions And Responsibilities

• Serve as the primary quality representative for military, government, and strategic customer accounts.
• Interpret customer specifications, contractual requirements, military standards, and regulatory requirements to ensure organizational compliance.
• Develop, review, and administer waivers, deviations, concessions, and other customer-approved exceptions.
• Lead customer communications regarding quality concerns, compliance issues, investigations, and corrective actions.
• Establish and maintain quality management systems that ensure compliance with customer, contractual, and regulatory requirements.
• Lead customer, government, regulatory, and third-party audits and assessments.
• Manage corrective actions resulting from audits, customer complaints, compliance findings, and internal investigations.
• Collaborate with Operations, Engineering, Supply Chain, Program Management, and other departments to ensure customer requirements are effectively implemented and maintained.
• Conduct risk assessments and facilitate root cause investigations to identify and mitigate operational and compliance risks.
• Monitor changes to customer requirements, military specifications, regulatory standards, and contractual obligations and implement necessary process improvements.
• Develop and maintain key performance indicators (KPIs) related to compliance, quality performance, customer satisfaction, and continuous improvement.
• Manage customer complaints, nonconformances, and compliance issues through investigation, containment, corrective action, and verification activities.
• Build and maintain strong relationships with customer representatives, government agencies, auditors, and regulatory authorities.
• Lead cross-functional teams in resolving complex customer and compliance-related challenges.
• Provide leadership, coaching, and development for personnel while supporting employee growth and succession planning.
• Manage departmental resources, budgets, and priorities to maximize efficiency and organizational effectiveness.
• Conduct performance reviews; develop growth plans; interpret, implement, and support employee-related policies, procedures, and programs.
• Support business growth initiatives, new program launches, and customer onboarding activities by ensuring compliance with contractual and regulatory requirements.
• Drive continuous improvement efforts focused on customer satisfaction, compliance performance, risk reduction, and operational excellence.
• Collaborate with production and supporting departments to ensure the food safety and quality of our products.
• Other duties, as assigned.

Education

Bachelor's degree in Quality Management, Engineering, Business Administration, Regulatory Affairs, Program Management, Operations Management, Supply Chain Management, or a related field preferred. Equivalent education, training, or relevant experience in a regulated industry may be considered in lieu of degree requirements.

Experience

5+ years of experience in quality, compliance, regulatory affairs, contract administration, engineering, program management, customer quality, or a related field. Experience working in a highly regulated industry is preferred. Demonstrated ability to interpret customer requirements, contractual obligations, and regulatory standards; manage audits, corrective actions, and compliance activities; and lead cross-functional efforts to resolve customer and operational issues. Experience working directly with customers, government agencies, auditors, or regulatory bodies is highly desirable.

Competencies

Customer Requirements Management, Customer Relationship Management, Contract Compliance, Regulatory Compliance, Regulatory Reporting, Quality Assurance, Reliability Analysis, Audit Management, Risk Assessment, Root Cause Analysis, Leadership, Problem-Solving, Project Management, Decision-Making, Strong Communication Skills, Stakeholder Influence, Continuous Improvement, and Operational Excellence.

Physical Requirements

Requires prolonged sitting and continuous use of computer. May lift, carry, push, or pull objects up to 10 lbs.